HIV AIDS News [International Conference on AIDS (12th: 1998: Geneva, Switzerland)]

Indinavir (IDV) in combination with Zidovudine (ZDV) and Lamivudine (3TC) in Treatmentnaive patients with >=500 CD4 cells/mm3(MSD protocol 060) [Abstract #12311]
12th World AIDS Conference
June 28 - July 3, 1998
Geneva, Switzerland
Randi Leavitt, Deborah McMahon, A. Meibohm, D. Aversa, R. Leavitt, D. Goodwin
Merck Research Laboratories, 10 Sentry Parkway, Blue Bell, PA; University of Pittsburgh,
Pittsburgh, PA; Glaxo Wellcome, Inc. Res. Triangle Prk. NC, USA
Objectives: To study the effects of IDV 800 mg q8h plus ZDV 300 mg q12h plus 3TC 150 mg
ql2h on long term suppression of serum viral RNA in treatment-naive patients with early HIV1 infection defined as CD4 cell counts >=500 cells/mm^A{3}, serum viral RNA (vRNA) >1000
copies/mL, and no history of HIV associated conditions. Methods: This is an ongoing 192 week
study. Currently 159 of a planned 250 patients have been enrolled with enrollment ongoing.
Preliminary antiretroviral activity was assessed by changes in vRNA obtained every 4 weeks
using both the Roche Amplicor and Ultra Sensitive assays. All samples reported as <400
copies/mL, using the Amplicor assay were reassayed using the Ultra Sensitive assay. Results:
Median entry vRNA was 7682 copies/mL. At week 4, 76% of 147 patients had vRNA below the
Amplicor assay level of quantification (400 copies/mL) and at week 24, 98% of 55 patients had
vRNA < 400 copies/mL. At week 4 and week 24 respectively, 14% of 91 patients and 97% of 39
patients with vRNA < 400 copies/mL also had vRNA < 50 copies/mL using the Ultra Sensitive
assay. Therapy has been generally well tolerated with a low rate of discontinuation.
Conclusions: In patients with early HIV-1 infection, IDV plus ZDV plus 3TC resulted in
suppression of vRNA below 400 copies/mL in 98% of patients by week 24 and <50 copies/mL
in 97% of those patients who were <400 copies/mL.